Human experimentation can have different meanings: indeed, with the development of medical research, therapeutic acts have to be distinguished from acts of cognitive values. For each kind of acts, specific conditions of acceptability and specific protections of human beings have to be defined.Human experimentation must be envisaged at different levels to evaluate ethical aspects: its scientific value, the risks, benefits envisaged, the populations implicated, etc…The individual consent must be present too in the relationship between the (...) subject and the doctors. In fact, is a real consent possible?Instead to insist on problems in terms of medical research, one would have to insist perhaps more on the fact that the medical practice in general would have to answer more to ethical grounds and to scientific rules. It is the non scientific medicine which is immoral and dangerous, as well the medicine with financial interests, or also the medecine without experimentation.The main arguments must remain at the level of the dignity of the persons, autonomy and freedom of choice must remain the fundamental values. (shrink)

Spectacular treatment disasters in recent years have made it clear that informal "let's-try-it-and-see" methods of testing new proposals are more risky now than ever before, and have led many to call for a halt to experimentation in clinical medicine. In this easy-tp-read, philosophical guide to human experimentation, William Silverman pleads for wider use of randomized clinical trials, citing many examples that show how careful trials can overturn preconceived or ill-conceived notions of a therapy's effectiveness and lead (...) to a clearer understanding of clinical anomalies. Because it gives careful guidance on setting up trials and avoiding conceptual pitfalls, this book will be of great interest to all epidemiologists and clinical statisticians, and to a wide varitey of clinicians, pharmacologists, and nurses. Since it requires no medical or statistical knowledge, it will also appeal to ethicists, lawyers, and the general public. (shrink)

Society has historically not taken a benign view of genetic disease. The laws permitting sterilization of the mentally re tarded~ and those proscribing consanguineous marriages are but two examples. Indeed as far back as the 5th-10th centuries, B.C.E., consanguineous unions were outlawed (Leviticus XVIII, 6). Case law has traditionally tended toward the conservative. It is reactive rather than directive, exerting its influence only after an individual or group has sustained injury and brought suit. In contrast, state legislatures have not been (...) inhibited in enacting statutes. Many of their products can be characterized as hasty, unnecessary, ill-conceived, and based on the heart rather than the head. Moreover the lack of expert consultation sought has also been remarkable. One state legislature, for example, has advocated immunization for sickle cell anemia! Many others have enacted laws for the screening of inborn errors of metabolism, e.g., phenylketon uria, but have poorly defined the lines of responsibility to secure compliance. A spate of specific disease-related bills has emerged in the u.S. Congress, each seeking recognition and appropriations. Sickle cell anemia, hemophilia, Cooley's anemia and Tay-Sachs disease have been among the front-runners for support. Finally, in 1975, Congress has begun to examine an omnibus bill concerning all forms of genetic disease. The bill, termed the National Genetic Diseases Act is, however, still far from being enacted. (shrink)

In this introduction, we address some of the complexities associated with the emergence of medicine’s bodies, not least as a means to ‘working with the body’ rather than simply producing a critique of medicine. We provide a brief review of some of the recent discussions on how to conceive of medicine and its bodies, noting the increasing attention now given to medicine as a technology or series of technologies active in constituting a multiplicity of entities – (...) bodies, diseases, experimental objects, the individualization of responsibility for health and even the precarity of life. We contrast what feminist theorists in the tradition of Judith Butler have referred to as the question of matter, and Science and Technology Studies with its focus on practice and the nature of emergence. As such we address tensions that exist in analyses of the ontological status of ‘the body’ – human and non-human – as it is enacted in the work of the laboratory, the randomized controlled trial, public health policy and, indeed, the market that is so frequently entangled with these spaces. In keeping with the recent turns toward ontology and affect, we suggest that we can regard medicine as concerned with the contraction and reconfiguration of the body’s capacities to affect and be affected, in order to allow for the subsequent proliferation of affects that, according to Bruno Latour, marks corporeal life. Treating both contraction and proliferation circumspectly, we focus on the patterns of affects wrought in particular by the abstractions of medicine that are described in the contributions to this special issue. Drawing on the work of A.N. Whitehead, we note how abstractions such as ‘medical evidence’, the ‘healthy human body’ or the ‘animal model’ are at once realized and undercut, mediated and resisted through the situated practices that eventuate medicine’s bodies. Along the way, we touch on the implications of this sort of perspective for addressing the distribution of agency and formulations of the ethical and the political in the medical eventuations of bodies. (shrink)

We live in an age of great scientific and technological innovation, and what seemed out of the question or at least very doubtful only a few years ago, today lies almost within our grasp. In no area is this more true than that of human health care, where lifesaving and life-enhancing technologies have given, or have the enormous potential in the not so distant future to give, relief from some of the most terrible human illnesses. On two fronts (...) in particular, xenograft or cross-species transplantation and genetic engineering of animals on behalf of gene therapy in humans, such relief appears very promising, if not actually on the horizon. Certainly, extensive research work on both fronts is underway both in the United States and abroad. (shrink)

This book focuses on experimentation that is carried out on human beings, including medical research, drug research and research undertaken in the social sciences. It discusses the ethics of such experimentation and asks the question: who defends the interests of these human subjects and ensures that they are not harmed? The author finds that ethical research depends on the adequacy of review by committee. Indeed most countries now rely on research ethics committees for the protection of (...) the interests of the human participants in research. Dr McNeill analyses how successful these committees are in balancing the interests of science with the interests of human subjects. (shrink)

The basic principles of scientific research from the great French physiologist whose contributions in the 19th century included the discovery of vasomotor nerves; nature of curare and other poisons in human body; more.

This new edition of Charles Fried's Medical Experimentation includes a general introduction by Franklin Miller and the late Alan Wertheimer, a reprint of the 1974 text, an in-depth analysis by Harvard Law School scholars I. Glenn Cohen and D. James Greiner, and a new essay by Fried reflecting on the original text and how it applies to the contemporary landscape of medicine and medical experimentation.

This is the first re-publication and first English translation of regulations concerning Human Experimentation which were binding law prior to and during the Third Reich, 1931 to 1945. The introduction briefly describes the duties of the Reichsgesundheitsamt, which formulated these regulations. It then outlines the basic concept of the Richtlinien for protecting subjects and patients on the one hand and for encouraging New Therapy and Human Experimentation on the other hand. Major issues, like personal responsibility of (...) the physician or researcher, teaching of ethics of research and therapy, and research and therapy on vulnerable populations, are compared with the regulations in the Nuremberg Code and subsequent regulations influenced by the Nuremberg Code. CiteULike Connotea Del.icio.us What's this? (shrink)

The case of women radium dial painters — women who tipped their brushes while painting the dials of watches and instruments with radioactive paint — has been extensively discussed in the medical and historical literature. Their painful and abhorrent deaths have occupied the interest of physicians, lawyers, politicians, military agencies, and the public. Hardly any discussion has concerned, however, the use of those women as experimental subjects in a number of epidemiological studies that took place from 1920 to 1990. This (...) article addresses the neglected issue of human experimentation in relation to the radium dial painters. Although women’s medical examinations have been classified as simple, routine measurements of radiation burden on the body and presented as a great offer to humanity, for more than fifty years those women had been repeatedly used as experimental subjects without proper consent. I argue that through this case it becomes obvious that the issue of defining what counts as human experimentation shifts from an epistemological to a serious ethical and political question, concerning the making of scientific knowledge while issues of gender related to this process are also discussed. (shrink)

All the powerful influences exertedby the subjective-interpersonal dimension onthe organic or technical-functional dimensionof sickness and health do not make anintersubjective test concerning medicaltherapeutic results impossible. Theseinfluences are not arbitrary; on the contrary,they obey laws that are de facto sufficientlystable to allow predictions and explanationssimilar to those of experimental sciences.While, in this respect, the rules concerninghuman action are analogous to the scientificlaws of nature, they can at any time be revokedby becoming aware of them. Law-like andreproducible regularities in the sciences ofman (...) are by no means separated from a patient'spersonal-hermeneutic mediation. This makes itpossible for human beings to modify, improve orsometimes even entirely (or better almostentirely) suspend these psychological,sociological, ethnological, medical,regularities. For this reason the sciences ofman including medicine are under the obligationof constantly inspecting the continuingvalidity of the rules on which theirpredictions and explanations are based, namelyby indirect, statistical methods. Thisrequires a synergistic collaboration ofextra-clinical and clinical tests through whichmedicine can obtain a good level ofintersubjective testability. (shrink)

The often-emphasized tension between the singularity of the patient and technical–scientific reproducibility in medicine cannot be resolved without a discussion of the epistemological and methodological status of the human sciences. On the one hand, the rules concerning human action are analogous to the scientific laws of nature. They are de facto sufficiently stable to allow predictions and explanations similar to those of experimental sciences. From this point of view, it is only a trivial truth, but still a (...) methodological irrelevancy, that the patient and the doctor–patient relationship represent an ontologically irreproducible reality. On the other hand, however, one can never exclude that one can fail in the application of "laws" of the human sciences to the individual patient, for such laws are by no means wholly separated from a patient's personal-hermeneutic mediation, and can at any time be revoked by becoming aware of them. This requires a synergistic collaboration of clinical and statistical methods, and shows a methodologically relevant sense in which one cannot disregard the singularity of the patient. The reason for the crucial role of the patient's singularity in medicine is every individual patient's capacity to revoke, in principle, routines and quasi-automatisms, even though the personal mediation by the patient's consciousness de facto changes them in such a small degree that predictions and explanations modeled in experimental science remain possible. (shrink)

In this article, I argue that it is wrong to conduct any experiment on a nonhuman which we would regard as immoral were it to be conducted on a human, because such experimentation violates the basic moral rights of sentient beings. After distinguishing the rights approach from the utilitarian approach, I delineate basic concepts. I then raise the classic “argument from marginal cases” against those who support experimentation on nonhumans but not on humans. After next replying to (...) six important objections against that argument, I contend that moral agents are logically required to accord basic moral rights to every sentient being. I conclude by providing criteria for distinguishing ethical from unethical experimentation. (shrink)

From an ethical standpoint, the goal of clinical research is to benefit patients. While individual investigations may not yield results that directly improve patients’ evaluation or treatment, the corpus of the research should lead in that direction. Without the goal of ultimate benefit to patients, such research fails as a moral enterprise. While this may seem obvious, the need to protect and benefit patients can get lost in the milieu of clinical research. Many advances in emergency medicine have been (...) based upon the results of research studies conducted both within the specialty and by others outside of the field. But has this research benefited patients? Has it followed the Hippocratic commitment “to do good or at least do no harm”? The answer is: yes, and no. This paper attempts to demonstrate this: first by citing advances from applied research that have benefited emergency department patients over the past three decades, and follows with some aspects of emergency medicine research that makes one question both its safety and its efficacy. While enormous gains have been made in patient care as a result of emergency medical research, ethical considerations complicate this rosy picture, and point to future areas of concern for researchers. (shrink)

This chapter contains sections titled: Scandalous Research in the Twentieth Century Basic Principles of Research Ethics Respect for Persons Beneficence Justice Conclusion.

This article explores the development of a novel biomedical research organism, and its potential to remake the species and spaces of translational medicine. The humanized mouse is a complex experimental object in which mice, rendered immunodeficient through genetic alteration, are engrafted with human stem cells in the hope of reconstituting a human immune system for biomedical research and drug testing. These chimeric organisms have yet to garner the same commentary from social scientists as other human–animal hybrid (...) forms. Yet, they are rapidly being positioned as central to translational medicine in immunological research and pharmaceutical development. This article explores the complex relations between species and spaces they seek to enact. Humanizing mice simultaneously moves these animal forms towards the intimate geographies of corporeal equivalence with humans and the expansive geographies of translational research. These multiple trajectories are achieved by the way humanized mice function as both uncertain ‘epistemic things’ and as expansive ‘collaborative things’, articulating mouse genetics with other research, notably stem cell science. In the context of post-genomics, their indeterminacy is critical to their collaborative value; their expansive potential follows as much from their biological openness as from specific expectations. Yet, these new research organisms have both accumulative and disruptive capacities, for there are patterns of interference between these trajectories, remaking boundaries between experimental practices and clinical contexts. (shrink)

Moral dilemmas can arise from uncertainty, including uncertainty of the real values involved. One interesting example of this is that of experimentation on human embryos and foetuses, If these have a moral stauts similar to that of human persons then there will be server constraitns on what may be done to them. If embryous have a moral status similar to that of other small clusters of cells, then constraints will be motivated largely by consideration for the persons (...) into whom the embryos may develop. If the truth lies somewhere between these two extremes, the embryo having neither the full moral weight of persons, nor a completely negligible moral weight, then different kinds of constraints will be appropriate. On the face of it, in order to know what kinds of experiements, if any, we are morally justified in performing on embryos we have to know what the moral weight of the embryo is. But then an impasse threatens, for it seems implausible that we can settle with certainty the exact moral status of the human embryo. It is the purpose of this paper to show that moral uncertainty need not make rational moral justification impossible. I develop a framework which distinguishes between what is morally right/wrong, and what is morally justified/unjustified, and applies standard decision theoretic tools to the case of moral uncertainties. (This was the first published account of what has subsequently become known as Expected Moral Value Theory. An earlier version of the paper, "A decision theoretic argument against human embryo experimentation", was published in M. Fricke (ed.), Essays in honor of Bob Durrant. (University of Otago Press, 1986) 111-27.). (shrink)

Ethics boards have become obligatory passage points in today's medical science, and we forget how novel they really are. The use of humans in experiments is an age-old practice that records show goes back to at least the third century BC and, since the early modern period, as a practice it has become increasingly popular. Yet, in most countries around the world, hardly any formal checks and balances existed to govern the communal oversight of experiments involving human subjects until (...) at least the 1960s. Ethics by Committee traces the rise of ethics boards for human experimentation in the second half of the twentieth century. Using the Netherlands as a case-study, Noortje Jacobs shows how the authority of physicians to make decisions about clinical research gave way in most developed nations to formal mechanisms of communal decision-making that served to regiment the behavior of individual researchers. This historically unprecedented change in scientific governance came out of a growing international wariness of medical research in the decades after World War II. Research ethics committees were originally intended not only to make human experimentation more ethical but also to raise its epistemic quality. By examining complex negotiations over the appropriate governance of human subjects research, Ethics by Committee advances our understanding not only of the history of research ethics and the randomized controlled trial but also, more broadly, of how liberal democracies in the late twentieth century have sought to resolve public concerns over charged issues in medicine and science. (shrink)

Recently, religious organisations, governments and public institutions have begun to offer apologies for historical wrongs. Can they legitimately do so? Departing from the tendency, Professor Hubert Markl, President of the Max Planck Society, has offered strong reasons for not apologising for the crimes of medical scientists who experimented on human subjects during the Nazi era. He argues that only the perpetrators can meaningfully apologise. Markl’'s position is considered and rejected in favour of the view that apologies by proxy for (...) historical wrongs are justifiable and should be made by institutions that have the authority to do so. (shrink)

Topics discussed in this work are abortion, euthanasia, medical negligence and human experimentation.

Bioethics; medical ethics; human experimentation in medicine; law and legislation.

Do terminally ill patients who have exhausted all other available, government-approved treatment options have a constitutional right to experimental treatment that may prolong their lives? On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach, held “Yes.” The plaintiffs, Abigail Alliance for Better Access to Developmental Drugs and Washington Legal Foundation, sought to enjoin the Food and Drug (...) Administration from refusing to allow the sale of investigational new drugs that had not yet received FDA approval. The terminally ill plaintiffs contended that they quite literally could not wait that long for the drugs. With no other treatment options available, the plaintiffs urged the court to recognize a fundamental, constitutional right to take potentially life-saving or life-prolonging drugs, even though the treatment had not been fully tested through human trials for safety and effectiveness and could not be legally marketed to the public. (shrink)

The theory of evolution has beenused in arguments regarding animalexperimentation. Two such arguments areanalyzed, one against and one in favor. Eachargument stresses the relevance of the theoryof evolution to normative ethics but attemptsexplicitly to avoid the so-called naturalisticfallacy.According to the argument against animalexperimentation, the theory of evolution`undermines' the idea of a special humandignity and supports `moral individualism'. Thelatter view implies that if it is wrong to usehumans in experiments, then it is also wrong touse animals, unless there are relevantdifferences between (...) them that justify adifference in treatment. No such differencescan be found with regard to animals which lead`biographical lives'.The argument in favor of animal experimentationis based on evolutionary psychology. It statesthat humans, as all social animals, arespeciesist by nature and stresses that thisshould be taken seriously in normative ethics.This does not mean that animal interests shouldnot be considered, only that vital humaninterests may outweigh them.In order to assess the arguments, one has totake a stand on certain more basic issues: `is'versus `ought', impartiality versus specialobligations, and feelings/intuitions versusreason. Given the author's own position withregard to these more basic considerations, theevolutionary argument in favor of animalexperimentation is judged to be more convincingthan the one against but not decisive. It isalso maintained that not all animal experimentsare acceptable. Which animal experiments areacceptable and which are not has to be decidedon a case-by-case basis. (shrink)

If one had to identify the biggest change within the philosophical tradition in the twenty-first century, it would certainly be the rapid rise of experimental philosophy to address differences in intuitions about concepts. It is, therefore, surprising that the philosophy of medicine has so far not drawn on the tools of experimental philosophy in the context of a particular conceptual debate that has overshadowed all others in the field: the long-standing dispute between so-called naturalists and normativists about the concepts (...) of health and disease. In this paper, I defend and advocate the use of empirical methods to inform and advance this and other debates within the philosophy of medicine. (shrink)

As Dobzhansky wrote, nothing in biology makes sense outside the context of the evolutionary theory, and this truth has not been sufficiently explored yet by medicine. We comment on Shanks and Pyles' recently published paper, Evolution and medicine: the long reach of "Dr. Darwin", and discuss some recent advancements in the application of evolutionary theory to carcinogenesis. However, we disagree with Shanks and Pyles about the usefulness of animal experiments in predicting human hazards. Based on the darwinian (...) observation of inter-species and inter-individual variation in all biological functions, Shanks and Pyles suggest that animal experiments cannot be used to identify hazards to human health. We claim that while the activity of enzymes may vary among individuals and among species, this does not indicate that critical events in disease processes occurring after exposure to hazardous agents differ qualitatively between animal models and humans. In addition, the goal is to avoid human disease whenever possible and with the means that are available at a given point in time. Epidemics of cancer could have been prevented if experimental data had been used to reduce human exposures or ban carcinogenic chemicals. We discuss examples. (shrink)

The author argues the following hypothesis: the medical clinic is an experimental practice, in the sense given to this term by Claude Bernard, and the clinic is its specific laboratory. Its object is not the disease, but the patient. Careful examination of the clinic attests to its very close proximity to the experimental method, and the comparison also raises a number of difficulties. The main obstacle arises from the specificity of medicine, which involves treating individual human subjects whose (...) words cannot be suppressed. Its main challenge is to combine a linguistic practice with an experimental method. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Philosophy of George Engel and the Philosophy of MedicineJeffrey P. Spike (bio)KeywordsGeorge Engel, psychosocial medicine, medical education, medical humanities, interviewing skills, philosophy of medicine, scientific methodDoctor Brad Lewis has encouraged us to consider George Engel’s philosophy with his excellent essay on Engel and Pragmatism. As a philosopher teaching full time in a medical school, it is refreshing to have an opportunity to analyze the work of (...) two physicians at this level of reflection and abstraction. It is even more of a pleasure because I knew Dr. Engel personally while I was teaching at the University of Rochester School of Medicine. I will make some observations of the philosophy behind Dr. Engel’s work, both published and practical, that is, as reflected in his writing but also in his influence in the medical curriculum at the institution that he called home for some thirty years (as seems appropriate when considering someone’s bona fides as a pragmatist).Engel’s Philosophy and Medicine’s PhilosophyGeorge Engel’s primary philosophical concern was to fight the powerful belief (or perhaps delusion) that medicine was evolving into a pure physical science, an extension of biochemistry and cell biology, or as we would now call them, proteomics and genomics. There is little evidence that he espoused any one methodology for basic science, so much as he opposed any one methodology for medicine. So to say he was a pragmatist seems underdetermined by his words, if that is taken to mean he advocated for changing the methodological model for scientific research. Rather the question is whether his preferred medical methodology is best characterized as pragmatic, or by some other description. On that score I agree with Lewis wholeheartedly.Of course, it might be that the claim of pragmatism is not meant to suggest a change in method for basic science, but to advocate for retaining an appreciation for the whole range of approaches to knowledge, from experimental science to epidemiology, and from epidemiology to acculturation. By that definition of pragmatism, Engel was indeed a pragmatist. Interpreted this way, he wanted medicine to stop worshipping the scientific method and appreciate that there are many paths to knowledge besides through the wet lab.It might be said that there are different scientific methods for different sciences, and Engel wanted us to appreciate that the reductionist methods [End Page 315] appropriate to the sciences of the small are not necessarily methods that can be applied to all sizes of objects we study, or all levels of reality (like the psychological and social). This is the truth about the world, although I am not sure that this is what Engel meant. As Lewis notes, Engel’s writing does sometimes sound as if he worshipped at the alter of science, as if all subjects of importance can be studied scientifically. But if he believed that, he was not correct. It might be, if all the subjects of the university that Lewis mentions are important, that some will turn out to be able to be studied in academically rigorous methods that are not scientific in any of the usual meanings of the word. Consider philosophy itself, for example.To the degree that it may stretch the evidence to say that Engel would have advocated for a pragmatic scientific method, it is still the case that pragmatism as outlined by Lewis and Engel’s biopsychosocial model can both be used to help medicine understand itself and overcome the temptation to idolize science. Medicine is not a science, or at least it is not just a science; in fact, I would suggest that it never was a science, and it will never be a science. Medicine is about health and illness, and uses whatever science it can to promote health and to treat (ameliorate or cure) illness.None of this should necessarily lead us to idolize pragmatism either. If each subject has its own ideal methodology for study, then it may be that pragmatism is the preferred method for, say, clinical judgment, whereas the scientific method is the best for the ‘hard’ sciences, and logic for philosophy. Or perhaps pragmatism and inductive logic are competing models for clinical... (shrink)

The emerging critique of alternative food networks (AFNs) points to several factors that could impede the participation of low-income, minority communities in the movement, namely, spatial and temporal constraints, and the lack of economic, cultural, and human capital. Based on a semi-experimental study that offers 6 weeks of free produce to 31 low-income African American households located in a New Orleans food desert, this article empirically examines the significance of the impeding factors identified by previous scholarship, through participant surveys (...) before, during, and after the program. Our results suggest economic constraints are more influential in determining where the participants shop for food than spatial and temporal constraints, and the study participants exhibit high levels of human and cultural capital regarding the purchase and consumption of locally grown produce. We also find them undeterred by the market’s predominantly White, middle-class cultural social space, which leads us to question the extent to which cultural exclusivity discourages their participation in AFNs. For all five factors we find that the constraints posed to accessing the local food market were not universal but varied among the participants. Finally, the study reveals some localized social constraints, fragmented social ties in particular, as a possible structural hurdle to engaging these residents in the alternative market in their neighborhood. Conclusions point to the need for a multi-dimensional and dynamic conceptualization of “food access.”. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- cause (...) the research involves the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (shrink)

How are we to appraise new technological developments that may bring revolutionary social changes? Currently this is often done by trying to predict or anticipate social consequences and to use these as a basis for moral and regulatory appraisal. Such an approach can, however, not deal with the uncertainties and unknowns that are inherent in social changes induced by technological development. An alternative approach is proposed that conceives of the introduction of new technologies into society as a social experiment. An (...) ethical framework for the acceptability of such experiments is developed based on the bioethical principles for experiments with human subjects: non-maleficence, beneficence, respect for autonomy, and justice. This provides a handle for the moral and regulatory assessment of new technologies and their impact on society. (shrink)

The moral status of human brain organoids (HBOs) has been debated in view of the future possibility that they may acquire phenomenal consciousness. This study empirically investigates the moral sensitivity in people’s intuitive judgments about actions toward conscious HBOs. The results showed that the presence/absence of pain experience in HBOs affected the judgment about the moral permissibility of actions such as creating and destroying the HBOs; however, the presence/absence of visual experience in HBOs also affected the judgment. These findings (...) suggest that people’s intuitive judgments about the moral status of HBOs are sensitive to the valence-independent value of phenomenal consciousness. We discuss how these observations can have normative implications; particularly, we argue that they put pressure on the theoretical view that the moral status of conscious HBOs is grounded solely in the valence-dependent value of consciousness. We also discuss how our findings can be informative even when such a theoretical view is finally justified or when the future possibility of conscious HBOs is implausible. (shrink)

How are we to appraise new technological developments that may bring revolutionary social changes? Currently this is often done by trying to predict or anticipate social consequences and to use these as a basis for moral and regulatory appraisal. Such an approach can, however, not deal with the uncertainties and unknowns that are inherent in social changes induced by technological development. An alternative approach is proposed that conceives of the introduction of new technologies into society as a social experiment. An (...) ethical framework for the acceptability of such experiments is developed based on the bioethical principles for experiments with human subjects: non-maleficence, beneficence, respect for autonomy, and justice. This provides a handle for the moral and regulatory assessment of new technologies and their impact on society. (shrink)

Experts from different disciplines offer novel ideas for improving research oversight and protection of human subjects.

Thus, Meyers provides a valuable account, not only of current medical attitudes, but also of relevant case and statute law as it stands at present.

Does reading poetry make you a better clinician?Can euthanasia be understood in terms of the meaning of a life?What is the moral and existential significance of ...

Creating simulations of the world can be a valuable way to test new ideas, predict the future, and broaden our understanding of a given topic. Presumably, the more similar the simulation is to the real world, the more transferable the knowledge generated in the simulation will be and, therefore, the more useful. As such, there is an incentive to create more advanced and representative simulations of the real world. Simultaneously, there are ethical and practical limitation to what can be done (...) in human and animal research, so creating simulated beings to stand in their place could be a way of advancing research while avoiding some of these issues. However, the value of representativeness implies that there will be an incentive to create simulated beings as similar to real-world humans as possible to better transfer the knowledge gained from that research. This raises important ethical questions related to how we ought to treat advanced simulated beings and consider if they might have autonomy and wellbeing concerns that ought to be respected. As such, the uncertainty and potential of this line of research should be carefully considered before the simulation begins. (shrink)

The 3Rs, or the replacement, reduction, and refinement of animal research, are widely accepted as the best approach to maximizing high-quality science while ensuring the highest standard of ethical consideration is applied in regulating the use of animals in scientific procedures. This contrasts with the muted scientific interest in the 3Rs when they were first proposed in The Principles of Humane Experimental Technique. Indeed, the relative success of the 3Rs has done little to encourage engagement with their original text, which (...) remains little read and out of print. By adopting a historical perspective, this article argues that one explanation for this disjunction may be found in another, more celebrated, event of 1959: C. P. Snow’s Rede lecture on The Two Cultures. The moral outlook of The Principles of Humane Experimental Technique derived from an earlier ethos wherein humanistic and scientific values occupied a shared culture. While the synthetic style of The Principles has hindered its readership, this article concludes that there is value to recovering the notion that the humanities and social sciences can contribute to the improvement of animal research. (shrink)

Because Plains Indians, as well as some other groups of Native Americans, generally perceived people and animals as closely related, medical therapies and preventive regimes in human and veterinary medical practice often overlapped. The sense of partnership that mounted people shared with their horses dictated that it was appropriate for certain equine remedies to be similar to those used for themselves. Horses, as well as people, could possess useful knowledge in the realm of curing. Reciprocity between humankind and nature (...) was expressed by the interactive healing powers of people and horses as well as by recorded examples of the connection that existed between human and equine health maintenance measures and medical procedures. (shrink)

This special issue aims to explore and investigate a new subfield, namely experimental philosophy of medicine. Whereas experimental philosophy is relatively new on the philosophical block, some of its takes and findings have already shaped central debates in ethics, philosophy of action, philosophy of language, and epistemology. Interestingly, the approach of this program was for a long time almost wholly ignored within bioethics and philosophy of medicine—although this seems to have changed somewhat recently. In this introduction, we briefly (...) sketch the program of experimental philosophy and how it can be used to shed philosophical light on issues in the philosophy of medicine. (shrink)

In this paper our aim is to examine whether research conducted on human participants with LSD-25 raises unique research ethical questions or demands particular concerns with regard to the design, conduct and follow-up of these studies, and should this be the case, explore and describe those issues. Our analysis is based on reviewing publications up to date which examine the clinical, research and other uses of LSD and those addressing ethical and methodological concerns of these applications, just as some (...) historical examinations of this subject. The first chapters of the paper give an overview regarding the history of LSD-research with human participants, healthy volunteers and patients alike. The remaining chapters have a focus on questions regarding the potential ethical issues of such human trials in the contemporary research ethics framework. We also consider briefly political and regulatory issues regarding this substance that possibly affect its clinical and research applications. (shrink)

This chapter describes the field of philosophy of medicine and its methods. We discuss the history and potential of experimental approaches in philosophy of medicine. We give an overview of the chapters in the book.

Several years ago, the University of Minnesota hosted a lecture by Alan Milstein, a Philadelphia attorney specializing in clinical trial litigation. Milstein, who does not mince words, insisted on calling research studies “experiments.” “Don't call it a study,” Milstein said. “Don't call it a clinical trial. Call it what it is. It's an experiment.” Milstein's comments made me wonder: when was the last time I heard an ongoing research study described as a “human experiment”? The phrase is now almost (...) always associated with abuses. Asking a prospective subject to sign up for a medical experiment would probably get roughly the same response as asking him or her to sign up for a police interrogation. It wasn't always this way. In the early days of American bioethics, scholars used the word “experimentation” in the same neutral way that they later began to use “research study” and “clinical trial.”. (shrink)

The concept of reproductive health promises to play a crucial role in improving health care provision and legal protection for women around the world. This is an authoritative and much-needed introduction to and defence of the concept of reproductive health, which though internationally endorsed, is still contested. The authors are leading authorities on reproductive medicine, women's health, human rights, medical law, and bioethics. They integrate their disciplines to provide an accessible but comprehensive picture. They analyse 15 cases from (...) different countries and cultures, and explore options for resolution. The aim is to equip readers to fashion solutions in their own health care circumstances, compatibly with ethical, legal and human rights principles. (shrink)